In Depth

While there is no shortage of challenges facing the food and beverage industry, one of the most prevalent issues today is
product liability claims resulting from foreign objects inadvertently incorporated into finished products. Despite the use
of numerous safeguards in a production facility, food manufacturers can never eliminate the possibility that a physical hazard
will be introduced during the manufacturing process. This is especially true where the hazard is an object that is intrinsic
to the product, such as bone or gristle.

Indiana’s Product Liability Act, Indiana Code §§ 34-20-1-1 through 34-20-9-1, governs all actions brought
by a user or consumer against a manufacturer or seller for physical harm caused by a product regardless of the theory of liability.
See Ind. Code § 34-20-1-1. The Act provides, in pertinent part:

a person who sells, leases, or otherwise puts into the stream of commerce any product in a defective condition unreasonably
dangerous to any user or consumer … is subject to liability for physical harm caused by that product to the user or
consumer … . Ind. Code § 34-20-2-1.

Thus, in order to prevail in a product liability action, “the plaintiff must prove that the product is in a defective
condition which renders it unreasonably dangerous.” Welch v. Scripto-Tokai Corp., 651 N.E.2d 810, 814 (Ind.
Ct. App. 1995).

“The requirement that the product be in a defective condition focuses on the product itself while the requirement that
the product be unreasonably dangerous focuses on the reasonable expectations of the consumer.” Id.
at 814 (emphasis added). Specifically, a product is in a defective condition if at the time it is conveyed by the seller to
another party, it is in a condition:

(1) not contemplated by reasonable persons among those considered expected users or consumers of the product; and

(2) that will be unreasonably dangerous to the expected user or consumer when used in reasonably expectable ways of handling
or consumption. Ind. Code § 34-20-4-1.

A product is also in a defective condition if the seller fails to give reasonable warnings or instructions to the consumer,
thereby leaving the product in an unreasonably dangerous condition. See Ind. Code § 34-20-4-2; Natural Gas
Odorizing, Inc. v. Downs, 685 N.E.2d 155, 162 (Ind. Ct. App. 1997), (“The Act imposes liability upon a manufacturer
who puts into the stream of commerce any product without a reasonably adequate warning thereby leaving it in an unreasonably
dangerous condition to any user, if such warning could be given in the exercise of reasonable diligence.”). However,
a product is unreasonably dangerous only if its use “exposes the user or consumer to a risk of physical harm
to an extent beyond that contemplated by the ordinary consumer who purchases it with the ordinary knowledge
about the product’s characteristics common to the community of consumers.” Ind. Code § 34-6-2-146 (emphasis
added).

Under this standard, when the object that causes an injury is a foreign material, such as a screw, a piece of metal or a
stone, a food manufacturer will be hard pressed to avoid liability. In that situation, an ordinary consumer with ordinary
knowledge of the product would not reasonably expect such an item to be present in the food. However, when the injury-causing
material is an item that is intrinsic to a finished product, a food manufacturer may be able to escape liability by arguing
that the injured consumer should have anticipated and guarded against the presence of the object in the food.

Although some courts rely on a distinction between foreign and natural characteristics of a food product to determine liability,
a majority of courts have adopted the “reasonable expectations test” to determine whether an ingredient that caused
the harm is an unanticipated adulteration or is an inherent aspect of the product. See, e.g., Morrison’s Cafeteria
of Montgomery, Inc. v. Haddox, 431 So. 2d 975, 978 (Ala. 1983) (applying the reasonable expectations test the court found,
as a matter of law, that a bone in a fish fillet did not disappoint such expectations); Clime v. Dewey Beach Enterprises,
831 F. Supp. 341, (D. Del. 1993), (holding, as a matter of law, that a consumer could not reasonably expect to receive a raw
clam free of injurious bacteria); Mathews v. Maysville Seafoods Inc., 602 N.E.2d 764, 765-66 (Ohio Ct. App. 1991)
(holding that a “consumer must reasonably anticipate and guard against the presence of a fish bone in a fish fillet”).
Under the reasonable consumer expectations test, substances that are natural to the preparation of the food served are to
be anticipated and, therefore, do not render the food unfit or defective. Mitchell. v. T.G.I. Friday’s, 748
N.E.2d 89 (Ohio Ct. App 2000).Thus, the reasonable consumer expectations test focuses on the final item sold to
the consumer and the expectations that are engendered by the type of preparation used in making the dish.

For example, in Mitchell v. T.G.I. Friday’s, the plaintiff was eating a fried clam strip when she bit into
a hard substance she believed to be a piece of a clam shell. Id. at 90. The plaintiff experienced immediate pain
and later required dental treatment for her injuries. Id. at 90-91. Consequently, the plaintiff filed a product liability
action against the restaurant that served the meal and the supplier of the fried clams. Id. at 91. Both defendants
filed motions for summary judgment, which the trial court granted. Id.

On appeal, the reviewing court began its analysis by summarizing the reasonable expectation test as “‘the test
… for what is “reasonably expected” by the consumer in the food as served, not what might be natural to
the ingredients of that food prior to preparation.’” Mitchell, 748 N.E.2d at 93 (quoting Mathews,
602 N.E.2d at 765). Thus, the Mitchell court concluded that the reasonable expectation test “is related to
the foreseeability of harm on the part of the defendant.” Id. (quoting Mathews, 602 N.E.2d at 765).
While the court noted that the test “usually presents a question for the jury,” it further stated that it “is
clear that in some cases the occurrence of a deleterious substance must be reasonably expected as a matter of law.”
Id. at 94. In fact, the court specifically stated that “‘[c]ourts cannot and must not ignore the common
experience of life and allow rules to develop that would make sellers of food or other consumer goods insurers of the products
they sell.’” Id. (quoting Morrison’s Cafeteria of Montgomery, Inc., 431 So. 2d at 979).
Applying the reasonable expectation test to the matter at hand, the court concluded that one who eats clams can reasonably
anticipate and guard against eating a piece of shell. See alsoAllen v. Grafton, 164 N.E.2d 167 (“Bones
which are natural to the type of meat served cannot legitimately be called a foreign substance, and a consumer who eats meat
dishes ought to anticipate and be on guard against the presence of such bones.”); Ruvolo v. Homovich, 778 N.E.
2d 661 (Ohio Ct. App. 2002), (holding that a consumer should reasonably anticipate the natural occurrence of chicken bone
fragments in a gordita sandwich).

While it has not explicitly been adopted by Indiana’s courts, the reasonable expectations test directly comports with
the Act’s definition of an unreasonably dangerous product. Consequently, where there is no dispute that the injury-causing
mechanism is an object intrinsic to the finished product, a food manufacturer should explore the consumer’s understanding
of the product, its preparation process and its raw ingredients early in the discovery process. A typical consumer will be
hard pressed to argue that he was unaware that the animal from which the product or its ingredients were derived originally
contained such an object. Accordingly, a food manufacturer may, through the filing of a dispositive motion, be able to convince
the trial court that it should apply the reasonable expectations test and find, as a matter of law, the injured consumer should
have reasonably anticipated and guarded against the presence of the object that caused their injury.

The reasonable expectations test is not the only defense a food manufacturer has to a product liability claim. Ind. Code
§ 24-20-5-1 provides that:

In a product liability action, there is a rebuttable presumption that the product that caused the physical harm was not defective
and that the manufacturer or seller of the product was not negligent if, before the sale by the manufacturer, the product:

(1) was in conformity with the general recognized state of the art applicable to the safety of the product at the time the
product was designed, manufactured, packaged and labeled; or

(2) complied with applicable codes, standards, regulations or specifications established, adopted, promulgated or approved
by the United States or by Indiana, or by any agency of the United States or Indiana.

Thus, when the object that causes an injury is an extrinsic object, such as a screw, a piece of metal or a stone, a food
manufacturer that adheres to a strict quality control program will have an avenue to try to avoid liability.

To reduce the inclusion of bone and gristle in their finished products, all food manufacturers use numerous preventative
measures and safeguards in their facilities. In light of these programs and process controls, an argument can be made that
the finished product, even when it contains foreign matter, was in conformity with the generally recognized state of the art
applicable to the safety of the product at the time it was designed, manufactured, packaged and labeled. This is particularly
true when, on the date the subject product was prepared and packaged, the manufacturer was operating its facility in compliance
with the applicable requirements of the United States Department of Agriculture and/or the United States Food and Drug Administration.
Thus, a food manufacturer should do everything it can to establish it has both a prerequisite program intended to prevent
foreign objects from entering its production line and process control steps that are designed to eradicate any materials that
are concealed in the raw materials used to make the finished product.

Although compelling in nature, a product liability claim resulting from a foreign object in a finished product is not an
automatic victory for the plaintiff. Caselaw from multiple jurisdictions supports the proposition that a consumer who eats
certain dishes ought to anticipate and be on the guard against the presence of certain foreign materials that may be contained
in those foods. Furthermore, even if a court were to find that an inclusion of a foreign object in the finished product renders
it unreasonably dangerous, the manufacturer may be entitled to use the rebuttable presumption that the product that caused
the physical harm was not defective and that the manufacturer or seller of the product was not negligent.•

Mr. Karns is a senior associate in the Indianapolis office of Frost Brown Todd. The opinions expressed in this article
are those of the author.

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